In this chapter, aspects of medicines regulation that specifically relate to pharmacovigilance are considered, focusing on the European Union. Legally, both the regulatory authorities and manufacturers are responsible for the safety of medicinal products. Both are obliged to operate pharmacovigilance systems...
The authors monitored the actions of national regulatory authorities (NRAs) from 10 low- and middle-income countries to identify the time lag between the issuance of safety alerts by these two stringent regulatory authorities and any actions by these select NRAs. Two NRAs outside Africa took ...
Pharmacovigilance in the US – an Industry Perspective Summary This chapter contains sections titled: Introduction Adverse event reporting requirements Requirements for reporting to regulatory authorities Elect... TM Hodge - John Wiley & Sons, Ltd 被引量: 8发表: 2009年 Brazilian pharmacovigilance system...
Through the project, SCOPE delivered guidance, training in key aspects of pharmacovigilance, and tools and templates to support best practice. The deliverables provide practical guidance that those working in the European national competent authorities can take to strengthen their national systems. The ...
Industry Health Authorities Relationships in Pharmacovigilance (PMS): The French Situation These relations do not hinder Health Authorities, whose decisions remain totally independent.Y. JuilletTherapeutic Innovation & Regulatory Science... Y Juillet - 《Therapeutic Innovation & Regulatory Science》 被引量:...
Some national health authorities and other international entities are considered relevant for the pharmaceutical industry around the whole world. For example, the American Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are act
Ascertaining the causality of suspected adverse drug reactions (ADRs) still remains a challenge in resource-limited settings. With the increasing and ever- more stringent regulations in pharmacovigilance, the regulatory authorities face greater demands for patient welfare and safety. In this review we ...
Clinical trials are essential for evaluating the safety and efficacy of new drugs before they are approved for use in patients. They involve testing the drug in humanvolunteersor patients under controlled conditions, following strict protocols. Pharmacovigilance is the ongoing monitoring of drug safety ...
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reactions of drugs, reports related to the quality of drugs while introducing drugs in order for the pharmaceutical business establishment to synthetize and report the information to Ministry of Heath's competent authority according to Ministry of Health-promulgated National guidance on pharmacovigilance. ...